Comparison Between Two Types of Sedation for Elective Upper Endoscopy Procedures

Sedation Complication Clinical Trial

Official title:

A Comparative Study Between Inhalational Sevoflurane Sedation With Intravenous Midazolam Sedation for Upper Endoscopy Procedure.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410211
• Other study ID #: 2018321-6154
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: May 2020
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sedation is defined as the act of administrating a sedative drug to produce a state of calm or sleep. Sedation is commonly given to a patient in hospital settings to provide a tolerable and pleasant experience by relieving anxiety, pain and discomfort, as well as to expedite the duration of the procedure. Moderate sedation (conscious sedation) is the preferred state of sedation, whereby self-maintenance of ventilation and hemodynamic stability is achieved.

The primary objective of this study is to determine if inhalational Sevoflurane is a more superior sedative agent in terms of faster psychomotor recovery and time taken to fulfil discharge criteria when compared with intravenous Midazolam sedation.

Secondary objective is to determine if inhalational Sevoflurane sedation has better patient's and endoscopist's satisfaction when compared with intravenous Midazolam sedation.

Description:

A randomized controlled trial study was done on patients undergoing elective upper gastrointestinal endoscopy in a single tertiary Centre in Malaysia. The study was approved by University Malaya Medical Centre medical research ethics committee. All patients gave written and informed consent. Patients were fasted, and three psychometric tests were performed as a baseline before sedation. Patients were randomly allocated to either receive IV Midazolam (Group M) or inhalational Sevoflurane (Group S) via nasal mask. Standard monitoring was applied. Patients in Sevoflurane group received the inhalational agent via a nasal mask with stepwise increment until and Observed Assessment of Alertness/Sedation Scale of 3 or maximum 1.0 minimum alveolar concentration was achieved. Patients in Midazolam group were given a stat dose of IV Midazolam 2.5mg. Both groups received 30mcg of IV Fentanyl and lignocaine 1% gargle prior to the procedure. The unblinded observer monitored the level of sedation and recorded the patient's vital signs. A second blinded observer performed the psychometric tests before and at the end of the procedure. He also recorded the time to fulfil discharge criteria as well as the satisfaction scores from the patient and endoscopist.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ASA I to II

• Patients who are not taking sedative agents prior to procedure.

• Patients who are able to give consent for the procedure.

Exclusion Criteria:

• Patients with ischaemic heart disease, respiratory diseases and cerebrovascular disease.

• Patients who are taking opioid or sedative medications 24 hours before procedure.

• Patients with previous history of adverse effects to Sevoflurane or Midazolam.

• Pregnant patients.

• Patients with airway obstructions.

• Patients with features of difficult airway such as limited neck extension, small mouth opening of less than 3 cm, mallampati score of more than 3.

• Patients who are at risk of aspiration. Impaired gag reflex, presence of neurological disorders and impaired physical mobility.

Related Conditions & MeSH terms

• Gastric Ulcer
• Gastro Esophageal Reflux
• Gastroesophageal Reflux
• Sedation Complication
• Stomach Ulcer

Intervention

Drug:
• Sevoflurane
Incidence of side effects such as excitation, headache, apnea, airway obstructions are recorded. Patients who experiences severe excitation disinhibition as defined in the investigator's opinion as agitation. Uncontrollable patient movements that causes unsafe procedural conditions and conversion to general anaesthesia is needed Post procedural recovery scoring are taken which includes: Time taken from the point that the procedure ended to the first OAAS score of 5 Time taken from (a) to meeting discharge eligilibility Pre and post procedure pyschometric test (delayed and immediate memory test, posting box test and Stroop test) will be done and compared by the blinded observer/investigator
• Midazolam injection
Incidence of side effects such as excitation, headache, apnea, airway obstructions are recorded. Patients who experiences severe excitation disinhibition as defined in the investigator's opinion as agitation. Uncontrollable patient movements that causes unsafe procedural conditions and conversion to general anaesthesia is needed Post procedural recovery scoring are taken which includes: Time taken from the point that the procedure ended to the first OAAS score of 5 Time taken from (a) to meeting discharge eligilibility Pre and post procedure pyschometric test (delayed and immediate memory test, posting box test and Stroop test) will be done and compared by the blinded observer/investigator.

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur	WP Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychomotor recovery time	Pre procedure psychomotor tests baseline scores will be obtained and compared with post procedure scores. Time to achieve baseline recovery scores will be taken and used to compare between the two sedative agents.	30 minutes from completion of procedure
Primary	Time taken to fulfil discharge criteria	Patient would have to fulfil a set of discharge criteria to ensure that patient is safe for discharge.	One day
Secondary	Patient and endoscopists satisfaction	Patient will answer a set of questionnaires to gauge the satisfaction of the sedation agent. Endoscopists will score their satisfaction with a scale of 1 to 10, with 1 - 3 being (dissatisfied), 4-6 (satisfied), and 7 - 10 (very satisfied)	Post procedure on the same setting not more than one day duration